A Study to Determine the Feasibility of Online Recruitment of People Using an Anti-Obesity Medication for Weight Loss

NCT06761703 | Completed FDA Device

• 1 other identifier: 20240163
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

This observational study is designed to determine the feasibility of recruitment from a digital research community of people using an anti-obesity medication for weight loss to understand willingness to consent to survey research and at home self-blood testing. This study will engage an active community of people using anti-obesity medications, semaglutide and tirzepatide, indicated for weight loss to examine the willingness of participants to engage in a digital study, provide consent, and complete various study-related tasks, including a self-collected capillary blood sample for assay testing and health related surveys.

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

• Number of Participants with Self-blood Draw Received by Central Laboratory

  30 days

Secondary Outcomes (7)

• Percentage of Consented Participants with Complete Self-reported Survey for Medical History

  Day 1

• Percentage of Consented Participants with Complete Self-reported Survey for Nausea and Nausea Management

  Day 1 and Day 30

• Percentage of Consented Participants with Complete Self-reported Survey for Patient Reported Outcomes in Obesity

  Day 1 and Day 30

• Percentage of Consented Participants with Complete Self-reported Survey for Partners in Health (PiH) Questionnaire

  Day 1 and Day 30

• Percentage of Consented Participants with Complete Self-reported Survey for the Daily Diary

  30 days

Study Arms (1)

Adults Using Anti-Obesity Medications

Adults using the anti-obesity medications, semaglutide and tirzepatide, indicated for weight loss to examine the willingness of patients to engage in a digital study, provide consent, and complete various study-related tasks.

Device: TAP® Micro Select Device (Touch Activated Phlebotomy)

Interventions

TAP® Micro Select Device (Touch Activated Phlebotomy) DEVICE

The TAP Micro Select device will be used in an investigational capacity by participants for self-collection of whole capillary blood.

Adults Using Anti-Obesity Medications

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults using the anti-obesity medications, semaglutide and tirzepatide, indicated for weight loss.

You may qualify if:

• Adults 18 - 80 years of age.
• Living in the United States.
• Consented from the Inspire online platform patient community for COSMOS-DIGITAL.
• Self-Reported current use of, and intention to continue for at least 30 days, one of the following medications for the indications of weight management/obesity:
• Semaglutide (wegovy)
• Tirzepatide (zepbound)

You may not qualify if:

• Currently receiving treatment in another investigational device or drug study, or participation in a current clinical trial.
• Self-reported sensitivity/allergy to any of the components of the self-draw collection device including stainless steel or elements commonly found in stainless steel.
• Self-reported fear of blood.
• Self-reported circulatory conditions causing difficulty in drawing capillary blood.
• Known history of bleeding diathesis or any coagulation disorder.
• History of skin disorders, abnormal skin integrity or atypical skin health within the areas to be tested in the upper arm.

Sponsors & Collaborators

• Amgen: lead

Study Sites (1)

YourBio Health/CRT

Medford, Massachusetts, 02155, United States

Location

Related Links

• AmgenTrials clinical trials website

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 1, 2025
• First Posted: January 7, 2025
• Study Start: November 14, 2024
• Primary Completion: January 6, 2025
• Study Completion: January 6, 2025
• Last Updated: January 14, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
• Access Criteria: Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.

Locations

US (1)